As the regulators continue to raise the bar for quality clinical research investigations, IMARC has released a whitepaper that discusses the principles of risk management and their application to clinical research.
The guidance documents for good clinical practice (GCP), ICH E6 and ISO14155, state the sponsor is responsible for quality assurance and quality control within a clinical trial. To achieve this, the sponsor must invest resources into these different aspects of a clinical trial. One specific aspect of integrating quality involves how risks are approached and managed throughout the course of a study. Both the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) released documents in 2013 focused on the integration of traditionally development and manufacturing quality principles, including risk-based approaches into the clinical research industry. FDA’s “Guidance for Industry: Oversight of Clinical Investigations—A Risk-Based Approach to Monitoring” and EMA’s “Reflection paper on risk based quality management in clinical trials” both describe how regulators now expect a quality, risk-based approach when conducting clinical research. These documents are examples of the shift toward quality techniques underway within industry when developing, initiating, and executing studies.
While risk management principles have always been a part of the medical device and drug development and manufacturing processes, these principles can successfully be translated and applied to risks present in clinical research. This whitepaper provides an introduction to risk management principles and describes how these principles can be applied to clinical research practice. Specific clinical research examples are also considered by following the risk management steps.
We invite you to download IMARC’s whitepaper and share your thoughts on the integration of quality principles and risk management techniques into clinical research. We hope this topic will generate an active discussion given the emphasis already placed on this topic by regulators. Please let us know your thoughts!